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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018454
Receipt No. R000021374
Scientific Title Changes of resistance-associated variants in HCV NS5A region post vitamin D supplementation for patients with chronic hepatitis C
Date of disclosure of the study information 2015/07/29
Last modified on 2020/04/29

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Basic information
Public title Changes of resistance-associated variants in HCV NS5A region post vitamin D supplementation for patients with chronic hepatitis C
Acronym Efficacy of vitamin D supplementation for resistance-associated variants in NS5A region
Scientific Title Changes of resistance-associated variants in HCV NS5A region post vitamin D supplementation for patients with chronic hepatitis C
Scientific Title:Acronym Efficacy of vitamin D supplementation for resistance-associated variants in NS5A region
Region
Japan

Condition
Condition Chronic hepatitis C
Classification by specialty
Hepato-biliary-pancreatic medicine Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To reveal the effect of vitamin D supplementation to the prevalence of resistance-associated variants in NS5A region.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The concentration of serum 25(OH)D3 after 16 weeks supplementation of vitamin D, and the prevalence of resistance-associated variants in NS5A region
Key secondary outcomes The changes in laboratory tests associated with liver function and fibrosis after 16 weeks supplementation of vitamin D.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Patients were treated with vitamin D supplementation (2000IU/day, once daily, after breakfast)for 16 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Chronic hepatitis C patients with resistance-associated variants in HCV NS5A region.
Key exclusion criteria 1. pregnant woman or lactating mother
2. poorly controlled heart failure
3. poorly controlled diabetes or hypertension
4. severe renal disorder
5. decompensated liver cirrhosis
6. other liver diseases, including autoimmune hepatitis, primary biliary cirrhosis and alcoholic hepatitis, liver failure
7. positive result for hepatitis B surface antigen and antibody to human immunodeficiency virus type-1
8. hypercarcemia
9. hyperparathyroidism
10. medication with other vitamin preparations
11. Judged by investigator not to be appropriate for inclusion in this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Atsukawa
Organization Nippon Medical School Chiba Hokusoh Hospital
Division name Division of Gastroenterology
Zip code
Address 1715,Kamakari,Inzai,Chiba, 270-1694, Japan
TEL 0476-99-1111
Email atsukawa-nms@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masanori Atsukawa
Organization Nippon Medical School Chiba Hokusoh Hospital
Division name Division of Gastroenterology
Zip code
Address 1715,Kamakari,Inzai,Chiba, 270-1694, Japan
TEL 0476-99-1111
Homepage URL
Email atsukawa-nms@umin.ac.jp

Sponsor
Institute Nippon Medical School Chiba Hokusoh Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 日本医科大学千葉北総病院(千葉県)/ Nippon Medical School Chiba Hokusoh Hospital(Chiba)

Other administrative information
Date of disclosure of the study information
2015 Year 07 Month 29 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 07 Month 22 Day
Date of IRB
2015 Year 07 Month 22 Day
Anticipated trial start date
2015 Year 07 Month 29 Day
Last follow-up date
2020 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 03 Month 30 Day

Other
Other related information

Management information
Registered date
2015 Year 07 Month 28 Day
Last modified on
2020 Year 04 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021374

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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